FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IRRIGATION SET W/BULB SYRINGE
K Number: K803200
·
Decision Jan 21, 1981
Classifications
1
FEI Numbers
368
Registration Numbers
368
Same Product Code
40
Applicant Total
11
Review Days
35
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- IRRIGATION SET W/BULB SYRINGE
- K Number
- K803200
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6960
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Walpak Co.
- Date Received
- December 17, 1980
- Decision Date
- January 21, 1981
- Product Code
- KYZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KYZ | Syringe, Irrigating (Non Dental) | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KYZ), ordered by most recent decision date.
OtoSet- Ear Cleaning System
FDA 510(k)
FDA Class 1
·General Hospital
SINGLE CANNULA EXTENDED APPLICATOR
FDA 510(k)
FDA Class 1
·General Hospital
TISSU TRANS HARVEST TUBING
FDA 510(k)
FDA Class 1
·General Hospital
TISSU-TRANS
FDA 510(k)
FDA Class 1
·General Hospital
QS DELIVERY SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
IRRIGATION SYRINGE KIT
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Walpak Co.
| K Number | Device Name | ||
|---|---|---|---|
| K803204 | IRRIGATION PISTON | Jan 21, 1981 | Substantially Equivalent |
| K803199 | SUTURE REMOVAL KIT | Jan 15, 1981 | Substantially Equivalent |
| K803198 | IRRIGATION SET W/PISTON SYRINGE | Jan 15, 1981 | Substantially Equivalent |
| K803201 | LEMON GLYCERINE SWABS | Dec 17, 1980 | Unknown |
| K802083 | CATHETER INSERTION TRAY | Sep 16, 1980 | Substantially Equivalent |
| K791598 | CLOSED SYSTEM FOLEY CATHERIZATION PROCED | Nov 16, 1979 | Substantially Equivalent |
| K780123 | CATHETERIZATION PROCEDURE TRAY | Feb 21, 1978 | Substantially Equivalent |
| K780124 | CATHETERIZATION PROCED. TRAY, URETHRAL | Feb 21, 1978 | Substantially Equivalent |
| K770446 | SPONGES, LAPAROTOMY | Jun 15, 1977 | Substantially Equivalent |
| K760560 | CATH CARE KIT | Nov 12, 1976 | Substantially Equivalent |